RATIONALE: Some drugs such as bleomycin or doxycycline, or other compounds like talc, may help to control fluid in the chest caused by cancer. It is not yet known if bleomycin, doxycycline, or talc is more effective in treating patients with malignant pleural effusions.

PURPOSE: Randomized phase III trial to compare the effectiveness of bleomycin, doxycycline, or talc in treating patients with malignant pleural effusions.

Condition	Treatment or Intervention	Phase
Quality of Life Malignant Pleural Effusion	Drug: bleomycin  Drug: doxycycline  Drug: talc	Phase III

Further Study Details: 

OBJECTIVES: I. Compare intrapleural bleomycin vs. doxycycline vs. talc in the treatment of malignant pleural effusion with respect to time to recurrence of the effusion.

II. Compare these treatments with respect to the necessity for further treatment of recurrent effusions.

III. Compare these treatments with respect to the extent of postinfusion complications, including pain and dyspnea.

IV. Compare these treatments with respect to duration of chest tube or soft catheter drainage required following pleurodesis.

V. Compare these treatments with respect to duration of hospitalization for retreatment of malignant pleural effusion following recurrence.

VI. Compare these treatments with respect to survival.

VII. Compare these treatments with respect to the impact of the procedure on pain and dyspnea.

PROTOCOL OUTLINE: This is a randomized trial. Patients are stratified by type of drainage device and participating institution.

All patients are randomized to undergo pleurodesis with bleomycin, doxycycline, or talc by indwelling pleural catheter. A second procedure is undertaken 72 hours later if pleural drainage is persistently large.

Patients are followed monthly for survival.

PROJECTED ACCRUAL: A total of 480 patients will be entered over 48 months.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Cytologically confirmed unilateral malignant pleural effusion or exudative effusion with positive biopsy from any tumor type; No chylous effusion
• Drainage of effusion with chest tube or soft catheter required; Lung re-expansion demonstrated on chest x-ray; Continuing drainage less than 250 mL/24 hours (or equivalent measured over 4 hours)

--Prior/Concurrent Therapy--

• No prior sclerosing agents on the affected side; No prior intrapleural therapy; No change in systemic therapy for at least 2 weeks prior to randomization
• Biologic therapy: Not specified
• Chemotherapy: No prior systemic bleomycin; Systemic chemotherapy allowed after pleurodesis
• Endocrine therapy: Hormone therapy allowed after pleurodesis
• Radiotherapy: No significant radiotherapy to affected hemithorax; Irradiation of painful bone lesions allowed on the affected side if field does not include a significant portion of the pleura
• Surgery: See Disease Characteristics; No prior thoracoscopic lysis of adhesions on the affected side

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0-2
• Hematopoietic: (within 2 weeks prior to entry); WBC greater than 2,000; Platelets greater than 50,000
• Hepatic: Not specified
• Renal: (within 2 weeks prior to entry); Creatinine less than 2.5 mg/dL OR Creatinine clearance greater than 40 mL/min
• Other: No pregnant or nursing women; Adequate contraception required of fertile patients

Study chairs or principal investigators

Robert L. Comis,  Study Chair,  Eastern Cooperative Oncology Group   
Michael J. O'Connell,  Study Chair

Study ID Numbers:  CDR0000065154; E-8592; NCI-P96-0076
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002872
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08